Optum Infusion Services 308 LLC — FDA Warning Letter Findings

You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area. Vermin are a source of microbial contamination. Therefore, your products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination.

Regarding your response to Observation 1 of the FDA 483, we acknowledge your response indicating that you will update the way you assess and document the risk associated with every “patient compound” potentially affected by an excursion and train staff on the new policy. Also, you stated that you have conducted a retrospective review of “compounds” referenced in the observation and found there to be no product or patient impact. However, your response lacked supporting…

An operator placed their gloved hands outside the ISO 5 area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood. It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated. C. Corrective Actions We have reviewed your firm’s responses to the Form FDA 483. Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation…

In response to Observation 2 of the Form FDA 483, you stated that you provided on-site training to staff. However, you did not provide the attachment Aseptic Technique Evaluation Update 04072022 referenced in your response. Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A. FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation. D.

In response to Observation 5 of the Form FDA 483, you stated that you changed pest control providers, installed insect light traps, and that you will be installing air curtains on exterior doors and plastic flap curtains inside of the warehouse door. It is unclear where the insect light traps, air curtains, or vortex curtains will be installed in relation to the classified areas. Additionally, it is unclear when these corrective actions will be fully implemented.